MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE; RELIA VAC

Catalog Number 0070800

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the balloon was deflated approximately 1 hour after placement.

Event Description

It was reported that the balloon was deflated approximately 1 hour after placement.

Manufacturer Narrative

The reported event was unconfirmed.The visual evaluation of the returned sample noted one reliavac evacuator with no original packaging present.The balloon easily fully expanded with no issues.The evacuator was connected to in house tubing and suctioned 400cc water as intended.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "reliavac® 400 closed wound suction evacuator kits contain wound drains and evacuators.Wound drains are made up of silicone and pvc materials; they are round or flat shape with perforations.They are packaged with or without a trocar.Evacuators are made of pvc materials.Ii.Indications for use: wound drains are used to remove exudates from wound sites.Iii.Contraindications: do not use for chest drainage.Iv.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.Do not use with wall suction in excess of 210mm hg.5.If the drain is occluded, irrigation and/or aspiration of the drain may be required.6.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.7.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.8.Suction must be discontinued prior to the removal of the drain.9.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector.¿ y-connector to suction source.10.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.V.Warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.2.Blood collected using the evacuator must not be re-infused as it may be a cause of potential infections.3.Do not use in patients who are allergic to materials used in bard® drain products.4.Do not bypass or inactivate the anti-reflux valve.5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting auxiliary suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying auxiliary suction directly to the drain.6.If an air-tight seal between the drain and the skin (from where the drain emerges) is not achieved, then air leak must be rectified or the system must be converted to open drainage.7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.8.Leaving the drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.9.Drain perforations must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.".

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Type of Device: RELIA VAC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8179830
• MDR Text Key: 131004466
• Report Number: 1018233-2018-06081
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049606
• UDI-Public: (01)00801741049606
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1